ID

35339

Beschreibung

ACP-196 in Combination With Obinutuzumab in Relapsed/Refractory or Untreated CLL/SLL/PLL; ODM derived from: https://clinicaltrials.gov/show/NCT02296918

Link

https://clinicaltrials.gov/show/NCT02296918

Stichworte

Versionen (1)
  1. 28.02.19 28.02.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

28. Februar 2019

DOI

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Eligibility Chronic Lymphocytic Leukemia NCT02296918

Englisch

Eligibility Chronic Lymphocytic Leukemia NCT02296918

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
• patients with a diagnosis of intermediate or high risk cll (or variant immunophenotype), sll, or b-pll by iwcll 2008 criteria (48) who have: previously received at least one therapy for their disease. previously untreated disease and 65 years old or under 65 years old and or refuse or are ineligible for chemoimmunotherapy
Beschreibung

Chronic Lymphocytic Leukemia Intermediate | High risk Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia Immunophenotype Variant | Small Lymphocytic Lymphoma | B-Cell Prolymphocytic Leukemia | Prior Therapy Quantity Disease | Disease Untreated | Age | Chemoimmunotherapy Refused | Ineligibility Chemoimmunotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0205103
UMLS CUI [2,1]
C4319571
UMLS CUI [2,2]
C0023434
UMLS CUI [3,1]
C0023434
UMLS CUI [3,2]
C0079611
UMLS CUI [3,3]
C0205419
UMLS CUI [4]
C0855095
UMLS CUI [5]
C0475801
UMLS CUI [6,1]
C1514463
UMLS CUI [6,2]
C1265611
UMLS CUI [6,3]
C0012634
UMLS CUI [7,1]
C0012634
UMLS CUI [7,2]
C0332155
UMLS CUI [8]
C0001779
UMLS CUI [9,1]
C2986423
UMLS CUI [9,2]
C1705116
UMLS CUI [10,1]
C1512714
UMLS CUI [10,2]
C2986423
• all patients must satisfy one of the following criteria for active disease requiring therapy: evidence of marrow failure as manifested by the development or worsening of anemia
Beschreibung

Disease Treatment required for | Pancytopenia | Development Anemia | Anemia Worsening

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332121
UMLS CUI [2]
C0030312
UMLS CUI [3,1]
C0678723
UMLS CUI [3,2]
C0002871
UMLS CUI [4,1]
C0002871
UMLS CUI [4,2]
C0332271
constitutional symptoms, which include any of the following:
Beschreibung

Constitutional Symptom

Datentyp

boolean

Alias
UMLS CUI [1]
C0009812
unintentional weight loss of 10% or more within 6 months
Beschreibung

Unintentional weight loss Percentage Timespan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2363736
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0872291
significant fatigue limiting activity
Beschreibung

Fatigue Limiting Activity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0026606
fevers ≥100.5 degrees f for 2 weeks or more without evidence of infection
Beschreibung

Fever Duration | Communicable Disease Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0332197
night sweats >1 month without evidence of infection
Beschreibung

Night sweats Duration | Communicable Disease Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0028081
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0332197
patients with a history of richter's transformation are eligible if they now have evidence of cll only, with <10% large cells in the bone marrow.
Beschreibung

Richter's syndrome | Chronic Lymphocytic Leukemia | Bone Marrow Cells Large Percentage

Datentyp

boolean

Alias
UMLS CUI [1]
C0349631
UMLS CUI [2]
C0023434
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0007634
UMLS CUI [3,3]
C0549177
UMLS CUI [3,4]
C0439165
ecog performance status ≤ 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of < 2 years or that would confound assessment of toxicity in this study
Beschreibung

Life Expectancy | Interference Assessment Toxicity

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0600688
must be ≥ 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
subject must have completed all cll therapies ≥ 4 weeks prior to first study dose.
Beschreibung

Treatment completed Chronic Lymphocytic Leukemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0580352
UMLS CUI [1,2]
C0023434
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any life-threatening illness, medical condition, or organ dysfunction which, in the investigator's opinion, could compromise the patients' safety, interfere with the absorption or metabolism of acp-196, or put the study outcomes at undue risk.
Beschreibung

Life threatening illness compromises Patient safety | Life threatening illness Interferes with Absorption ACP-196 | Life threatening illness Interferes with Metabolism ACP-196 | Life threatening illness Research results At risk | Medical condition compromises Patient safety | Medical condition Interferes with Absorption ACP-196 | Medical condition Interferes with Metabolism ACP-196 | Medical condition Research results At risk | Organ dysfunction compromises Patient safety | Organ dysfunction Interferes with Absorption ACP-196 | Organ dysfunction Interferes with Metabolism ACP-196 | Organ dysfunction Research results At risk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3846017
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C3846017
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C3827171
UMLS CUI [3,1]
C3846017
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0025519
UMLS CUI [3,4]
C3827171
UMLS CUI [4,1]
C3846017
UMLS CUI [4,2]
C0683954
UMLS CUI [4,3]
C1444641
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C2945640
UMLS CUI [5,3]
C1113679
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0237442
UMLS CUI [6,4]
C3827171
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0025519
UMLS CUI [7,4]
C3827171
UMLS CUI [8,1]
C3843040
UMLS CUI [8,2]
C0683954
UMLS CUI [8,3]
C1444641
UMLS CUI [9,1]
C0349410
UMLS CUI [9,2]
C2945640
UMLS CUI [9,3]
C1113679
UMLS CUI [10,1]
C0349410
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C0237442
UMLS CUI [10,4]
C3827171
UMLS CUI [11,1]
C0349410
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0025519
UMLS CUI [11,4]
C3827171
UMLS CUI [12,1]
C0349410
UMLS CUI [12,2]
C0683954
UMLS CUI [12,3]
C1444641
female subjects who are pregnant or breastfeeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects with active cardiovascular disease not medically controlled or those who have had myocardial infarction in the past 6 months.
Beschreibung

Cardiovascular Disease Uncontrolled | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0027051
malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
Beschreibung

Malabsorption Syndrome | Disease Affecting Gastrointestinal function | Gastrectomy | Small intestine excision | Ulcerative Colitis | Inflammatory Bowel Disease Symptomatic | Partial bowel obstruction | Intestinal Obstruction Complete

Datentyp

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0516983
UMLS CUI [3]
C0017118
UMLS CUI [4]
C0192601
UMLS CUI [5]
C0009324
UMLS CUI [6,1]
C0021390
UMLS CUI [6,2]
C0231220
UMLS CUI [7]
C1328480
UMLS CUI [8,1]
C0021843
UMLS CUI [8,2]
C0205197
major surgery within 4 weeks before first dose of study drug.
Beschreibung

Major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
history of stroke or intracranial hemorrhage within 6 months before the first dose of study drug.
Beschreibung

Cerebrovascular accident | Intracranial Hemorrhages

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0151699
subjects with human immunodeficiency virus (hiv) or active infection with hepatitis c virus (hcv) or hepatitis b virus (hbv) or any uncontrolled active systemic infection
Beschreibung

HIV Infection | Hepatitis C | Hepatitis B | Sepsis Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019163
UMLS CUI [4,1]
C0243026
UMLS CUI [4,2]
C0205318
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Ähnliche Modelle

Eligibility Chronic Lymphocytic Leukemia NCT02296918

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia Intermediate | High risk Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia Immunophenotype Variant | Small Lymphocytic Lymphoma | B-Cell Prolymphocytic Leukemia | Prior Therapy Quantity Disease | Disease Untreated | Age | Chemoimmunotherapy Refused | Ineligibility Chemoimmunotherapy
Item
• patients with a diagnosis of intermediate or high risk cll (or variant immunophenotype), sll, or b-pll by iwcll 2008 criteria (48) who have: previously received at least one therapy for their disease. previously untreated disease and 65 years old or under 65 years old and or refuse or are ineligible for chemoimmunotherapy
boolean
C0023434 (UMLS CUI [1,1])
C0205103 (UMLS CUI [1,2])
C4319571 (UMLS CUI [2,1])
C0023434 (UMLS CUI [2,2])
C0023434 (UMLS CUI [3,1])
C0079611 (UMLS CUI [3,2])
C0205419 (UMLS CUI [3,3])
C0855095 (UMLS CUI [4])
C0475801 (UMLS CUI [5])
C1514463 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0012634 (UMLS CUI [6,3])
C0012634 (UMLS CUI [7,1])
C0332155 (UMLS CUI [7,2])
C0001779 (UMLS CUI [8])
C2986423 (UMLS CUI [9,1])
C1705116 (UMLS CUI [9,2])
C1512714 (UMLS CUI [10,1])
C2986423 (UMLS CUI [10,2])
Disease Treatment required for | Pancytopenia | Development Anemia | Anemia Worsening
Item
• all patients must satisfy one of the following criteria for active disease requiring therapy: evidence of marrow failure as manifested by the development or worsening of anemia
boolean
C0012634 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0030312 (UMLS CUI [2])
C0678723 (UMLS CUI [3,1])
C0002871 (UMLS CUI [3,2])
C0002871 (UMLS CUI [4,1])
C0332271 (UMLS CUI [4,2])
Constitutional Symptom
Item
constitutional symptoms, which include any of the following:
boolean
C0009812 (UMLS CUI [1])
Unintentional weight loss Percentage Timespan
Item
unintentional weight loss of 10% or more within 6 months
boolean
C2363736 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Fatigue Limiting Activity
Item
significant fatigue limiting activity
boolean
C0015672 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0026606 (UMLS CUI [1,3])
Fever Duration | Communicable Disease Absent
Item
fevers ≥100.5 degrees f for 2 weeks or more without evidence of infection
boolean
C0015967 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Night sweats Duration | Communicable Disease Absent
Item
night sweats >1 month without evidence of infection
boolean
C0028081 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Richter's syndrome | Chronic Lymphocytic Leukemia | Bone Marrow Cells Large Percentage
Item
patients with a history of richter's transformation are eligible if they now have evidence of cll only, with <10% large cells in the bone marrow.
boolean
C0349631 (UMLS CUI [1])
C0023434 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0007634 (UMLS CUI [3,2])
C0549177 (UMLS CUI [3,3])
C0439165 (UMLS CUI [3,4])
ECOG performance status
Item
ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy | Interference Assessment Toxicity
Item
life expectancy of < 2 years or that would confound assessment of toxicity in this study
boolean
C0023671 (UMLS CUI [1])
C0521102 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0600688 (UMLS CUI [2,3])
Age
Item
must be ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Treatment completed Chronic Lymphocytic Leukemia
Item
subject must have completed all cll therapies ≥ 4 weeks prior to first study dose.
boolean
C0580352 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Life threatening illness compromises Patient safety | Life threatening illness Interferes with Absorption ACP-196 | Life threatening illness Interferes with Metabolism ACP-196 | Life threatening illness Research results At risk | Medical condition compromises Patient safety | Medical condition Interferes with Absorption ACP-196 | Medical condition Interferes with Metabolism ACP-196 | Medical condition Research results At risk | Organ dysfunction compromises Patient safety | Organ dysfunction Interferes with Absorption ACP-196 | Organ dysfunction Interferes with Metabolism ACP-196 | Organ dysfunction Research results At risk
Item
any life-threatening illness, medical condition, or organ dysfunction which, in the investigator's opinion, could compromise the patients' safety, interfere with the absorption or metabolism of acp-196, or put the study outcomes at undue risk.
boolean
C3846017 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3846017 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C3827171 (UMLS CUI [2,4])
C3846017 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0025519 (UMLS CUI [3,3])
C3827171 (UMLS CUI [3,4])
C3846017 (UMLS CUI [4,1])
C0683954 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0237442 (UMLS CUI [6,3])
C3827171 (UMLS CUI [6,4])
C3843040 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0025519 (UMLS CUI [7,3])
C3827171 (UMLS CUI [7,4])
C3843040 (UMLS CUI [8,1])
C0683954 (UMLS CUI [8,2])
C1444641 (UMLS CUI [8,3])
C0349410 (UMLS CUI [9,1])
C2945640 (UMLS CUI [9,2])
C1113679 (UMLS CUI [9,3])
C0349410 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C0237442 (UMLS CUI [10,3])
C3827171 (UMLS CUI [10,4])
C0349410 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0025519 (UMLS CUI [11,3])
C3827171 (UMLS CUI [11,4])
C0349410 (UMLS CUI [12,1])
C0683954 (UMLS CUI [12,2])
C1444641 (UMLS CUI [12,3])
Pregnancy | Breast Feeding
Item
female subjects who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cardiovascular Disease Uncontrolled | Myocardial Infarction
Item
subjects with active cardiovascular disease not medically controlled or those who have had myocardial infarction in the past 6 months.
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
Malabsorption Syndrome | Disease Affecting Gastrointestinal function | Gastrectomy | Small intestine excision | Ulcerative Colitis | Inflammatory Bowel Disease Symptomatic | Partial bowel obstruction | Intestinal Obstruction Complete
Item
malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
boolean
C0024523 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0516983 (UMLS CUI [2,3])
C0017118 (UMLS CUI [3])
C0192601 (UMLS CUI [4])
C0009324 (UMLS CUI [5])
C0021390 (UMLS CUI [6,1])
C0231220 (UMLS CUI [6,2])
C1328480 (UMLS CUI [7])
C0021843 (UMLS CUI [8,1])
C0205197 (UMLS CUI [8,2])
Major surgery
Item
major surgery within 4 weeks before first dose of study drug.
boolean
C0679637 (UMLS CUI [1])
Cerebrovascular accident | Intracranial Hemorrhages
Item
history of stroke or intracranial hemorrhage within 6 months before the first dose of study drug.
boolean
C0038454 (UMLS CUI [1])
C0151699 (UMLS CUI [2])
HIV Infection | Hepatitis C | Hepatitis B | Sepsis Uncontrolled
Item
subjects with human immunodeficiency virus (hiv) or active infection with hepatitis c virus (hcv) or hepatitis b virus (hbv) or any uncontrolled active systemic infection
boolean
C0019693 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0243026 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
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